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Use of PET/MR Imaging in Chronic Pain

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Stanford University

Status and phase

Completed
Phase 1

Conditions

Chronic Pain

Treatments

Device: PET/MRI
Drug: [18F]FDG

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03195270
IRB-24972

Details and patient eligibility

About

The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG) to objectively identify and characterize pain generators in patients suffering from chronic pain.

Full description

The diagnosis and management of chronic and neuropathic pain syndromes remains a major clinical challenge, and this failure is partly attributed to our inability to identify the hypersensitive and inflammatory changes in the pain-sensing part of our nervous system that is thought to contribute to these syndromes. The lack of a specific, objective diagnostic test for chronic and neuropathic pain syndromes can result in a delay of diagnosis and suboptimal management decisions. This delay in diagnosis is quite unfortunate since the early diagnosis and treatment of a disease is attributed to the highest probability of remission in certain chronic pain syndromes. Additionally, identifying the correct source of pain is of paramount importance since the clinical course and therapeutic interventions are different depending on cause.

Evidence in the literature points strongly toward an active inflammatory component in chronic pain. For example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. Similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. It is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as [18F]fluorodeoxyglucose ([18F]FDG). Correspondingly, [18F]FDG positron emission tomography-magnetic resonance imaging (PET/MRI) represent leading FDA-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. One of the goals of the study is to determine whether [18F]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18 years or older.
  • Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine.
  • Provides informed consent
  • On a typical day, pain level of at least 4/10 on a 0-10 Comparative Pain Scale
  • Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion criteria

  • MRI-incompatible
  • Diabetes
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

88 participants in 1 patient group

Single Arm
Experimental group
Description:
\[18F\]FDG PET/MRI
Treatment:
Device: PET/MRI
Drug: [18F]FDG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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